IBUPROFEN  - ibuprofen tablet, coated 
IBUPROFEN - ibuprofen tablet, coated 
Polygen Pharmaceuticals LLC

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Ibuprofen Tablets,  200 mg

Active ingredient(s)


Ibuprofen 200 mg (NSAID)*

 * nonsteroidal anti-inflammatory drug


Purpose


Pain reliever/Fever reducer


Use(s)

temporarily relieves minor aches and pain due to:

Warnings

Allergy alert: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin.

Symptoms may include: 


If an allergic reaction occurs, stop use and seek medical help right away.


Stomach bleeding warning:
This product contains an NSAID, which may cause stomach bleeding. The chance is higher if you:

Do not use


Ask a doctor before use if

Ask a doctor or pharmacist before use if

When using this product

Stop use and ask doctor if

Side effects occur. You may report side effects to PolyGen at 1-888-291-7337 and/ or FDA at 1-800-FDA-1088

Pregnancy/Breastfeeding


ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children


In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)


Directions


adults and children
12 years and older:
· take 1 tablet every 4 to 6 hours while symptoms persist
· if pain or fever does not respond to 1 tablet, 2 tablets may be used
· do not exceed 6 tablets in 24 hours unless directed by a doctor
children under 12 years:
ask a doctor

other information



Inactive ingredient


colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Storage

Questions


1-888-291-7337


Principal Display Panel


CARTON LABEL PDP

 

NDC: 52605-114-01

 

Compare to the active ingredient in Advil®

 

IBUPROFEN TABLETS, USP 200 mg

PAIN RELIEVER/ FEVER REDUCER (NSAID)

 

100 COATED TABLETS

 

SEE NEW WARNINGS INFORMATION
 


Ibuprofen


BOTTLE LABEL PDP

NDC: 52605-114-01

 

IBUPROFEN TABLETS, USP 200 mg

PAIN RELIEVER/ FEVER REDUCER(NSAID)

 

100 COATED TABLETS

 

SEE NEW WARNINGS INFORMATION



ibu200tabbottlab


CARTON LABEL PDP

 

NDC: 52605-117-01

 

Compare to the active ingredient in Advil®

 

IBUPROFEN TABLETS, USP 200 mg

PAIN RELIEVER/ FEVER REDUCER (NSAID)

 

100 COATED CAPLETS

 

SEE NEW WARNINGS INFORMATION



ibucarton100






BOTTLE LABEL PDP

NDC: 52605-117-01

 

IBUPROFEN TABLETS, USP 200 mg

PAIN RELIEVER/ FEVER REDUCER(NSAID)

 

100 COATED CAPLETS

 

SEE NEW WARNINGS INFORMATION



ibubott100




IBUPROFEN  
ibuprofen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52605-114
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 114
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52605-114-01 1 in 1 CARTON
1 100 in 1 BOTTLE
2 NDC:52605-114-10 1000 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091239 06/05/2012
IBUPROFEN 
ibuprofen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52605-117
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
Product Characteristics
Color BROWN Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code 117
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52605-117-01 1 in 1 CARTON
1 100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091239 06/05/2012
Labeler - Polygen Pharmaceuticals LLC (962415720)
Registrant - Polygen Pharmaceuticals LLC (962415720)
Establishment
Name Address ID/FEI Business Operations
Marksans Pharma Limited 925822975 MANUFACTURE(52605-117)

Revised: 6/2013
Document Id: c265106e-3575-4073-8195-0aa0adb10f45
Set id: 00bc1e01-f90e-444d-b7d6-807797a1d136
Version: 6
Effective Time: 20130627
 
Polygen Pharmaceuticals LLC